UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014647 |
|---|---|
| Receipt number | R000016989 |
| Scientific Title | Study of the usefulness and safety of a robot support operation using da Vinci S(Si) Surgical System for General Thoracic Surgery |
| Date of disclosure of the study information | 2014/07/25 |
| Last modified on | 2018/06/18 19:13:57 |
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Basic information
Public title
Study of the usefulness and safety of a robot support operation using da Vinci S(Si) Surgical System for General Thoracic Surgery
Acronym
Study of the usefulness and safety of a robot support operation using da Vinci S(Si) Surgical System for General Thoracic Surgery
Scientific Title
Study of the usefulness and safety of a robot support operation using da Vinci S(Si) Surgical System for General Thoracic Surgery
Scientific Title:Acronym
Study of the usefulness and safety of a robot support operation using da Vinci S(Si) Surgical System for General Thoracic Surgery
Region
| Japan |
Condition
Condition
lung and mediastinal disease
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We use the da Vinci S(Si) Surgical System for thoracic diseases and evaluate afety and efficacy of robotic surgery for thoracic surgery fields in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Robotic surgery is an effective surgical method.
1.Operation time and operative blood loss
2.Intraoperative and postoperative complication
3.Postoperative progress
4.Pathological finding
Key secondary outcomes
1.Disease free survival
2.Overall survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Robot-assiated surgery using da Vinci S (Si) Surgical System for lung or mediastinal disease 15 cases
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with a document agreement, who is recommended for resection for the lung or mediastinal disease under thoracoscopic surgery
Key exclusion criteria
Patients who is not recommended for resection for the lung or mediastinal disease under thoracoscopic surgery,or patients whom the principal investigator or the assignment researcher judges to be unsuitable to this research paticipation
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Meinoshin Okumura |
Organization
Osaka University Hospital
Division name
Department of General Thoracic Surgery
Zip code
Address
2-2-L5, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3152
meinosin@thoracic.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Shintani |
Organization
Osaka University Graduate School of Medicine
Division name
Department of General Thoracic Surgery
Zip code
Address
2-2-L5, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3152
Homepage URL
yshintani@thoracic.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Hospital, Department of General Thoracic Surgery, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of General Thoracic Surgery, Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 25 | Day |
Last modified on
| 2018 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016989
